NMPA Approved 73 Medical Devices in October 2020
In October 2020, NMPA has approved a total of 73 medical devices. 48 of them are domestic Class III medical devices, 14 of them are imported Class III medical devices, 10 of them are imported Class II medical devices and one of them is a Taiwan medical device.
Link: https://www.nmpa.gov.cn/xxgk/ggtg/ylqxpzhzhcchpgg/20201118092647175.html
Please find the approved imported medical devices in October 2020 as below. If you want to know more about your device category, clinical pathways, predicate information and other related to your China business, please do not hesitate to contact us at info@inspirativemed.com.
Approved Imported Medical Devices in October 2020
| No. |
Product Name |
Registrant Name |
Certificate Number |
| Imported Class III Medical Devices |
| 1. |
CalSet PIVKA-II |
Roche Diagnostics GmbH |
国械注进20203400441 |
| 2. |
Dental laser selection melts cobalt – chromium alloy powder |
S&S Scheftner GmbH |
国械注进20203170442 |
| 3. |
Dental Titanium and Titanium Alloy Abutments and Accessories |
DENTSPLY Implants Manufacturing GmbH |
国械注进20203170443 |
| 4. |
ZytoLight SPEC HER2/CEN17 Dual Color Probe Kit) |
ZytoVision GmbH |
国械注进20203400450 |
| 5. |
Human immunodeficiency virus antigen and antibody combined test calibration product |
Ortho-Clinical Diagnostics |
国械注进20203400451 |
| 6. |
Intra-Aortic Balloon Pump System |
Arrow International,Inc. |
国械注进20203080452 |
| 7. |
MiSeqTMDx Instrument |
Illumina, Inc. |
国械注进20203220453 |
| 8. |
Ultrasound System |
Siemens Medical Solutions USA, Inc. |
国械注进20203060454 |
| 9. |
CXI Support Catheter |
ReFlow Medical,Inc. |
国械注进20203030455 |
| 10. |
Resin-based Dental Restorative Material |
株式会社トクヤマデンタル |
国械注进20203170456 |
| 11. |
Distal Radius Sterile Kit |
Synthes GmbH |
国械注进20203130457 |
| 12. |
WECK® Auto Endo5® Automatic Endoscopic Applier |
Teleflex Medical |
国械注进20203020458 |
| 13. |
OCS-B Osteo Conductive Substitute-Bovine |
NIBEC Jincheon Factory Co.,Ltd. |
国械注进20203170459 |
| 14. |
proGAV 2.0® Sterile, single-use adjustable valve hydrocephalus shunt and components system |
Christoph Miethke GmbH&Co.KG |
国械注进20203130460 |
| Imported Class II Medical Devices |
| 15. |
Recording Electrodes |
Natus Manufacturing Limited |
国械注进20202070437 |
| 16. |
Breast pump |
Medela AG |
国械注进20202140438 |
| 17. |
Dental optical impression system |
MEDIT Corp. |
国械注进20202170439 |
| 18. |
Cystatin C 2 Assay （CYSC 2） |
Siemens Healthcare Diagnostics Inc. |
国械注进20202400440 |
| 19. |
Non-Contact Tonometer |
Huvitz Co., Ltd. |
国械注进20202160444 |
| 20. |
Versicon Irrigation Pump |
joimax GmbH |
国械注进20202060445 |
| 21. |
Diagnostic Ultrasound Scanner |
삼성메디슨（주） |
国械注进20202060446 |
| 22. |
Sleep Apnea Therapy SYSTEM |
Somnetics International,Inc. |
国械注进20202080447 |
| 23. |
Power System |
ConMed Corporation |
国械注进20202040448 |
| 24. |
Metal Brackets |
Ormco Corporation |
国械注进20202170449 |
| Medical Device from Taiwan |
| 25. |
Soft Contact lens |
Xingou Optics Co., LTD |
国械注许20203160014 |
|
